FAMOTIDINE- famotidine injection 
Zydus Lifesciences Limited

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Famotidine Injection, USP
Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1846-6

Famotidine Injection USP, 40 mg/4 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

10 X 4 mL Multiple-Dose Vials

 

Rx Only

40 mg/4 mL (10 mg/mL) carton label

NDC 70771-1846-1

Famotidine Injection USP, 40 mg/4 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

4 mL Multiple-Dose Vials

Rx only

40 mg/4 mL (10 mg/mL) vial label

NDC 70771-1847-6

Famotidine Injection USP, 200 mg/20 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

10 X 20 mL Multiple-Dose Vials

Rx only

200 mg/20 mL (10 mg/mL) carton label

NDC 70771-1847-1

Famotidine Injection USP, 200 mg/20 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

20 mL Multiple-Dose Vials

Rx only

200 mg/20 mL (10 mg/mL) vial label

NDC 70771-1845-7

Famotidine Injection USP, 20 mg/2 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

25 X 2 mL Single-Dose Vials

Rx only

20 mg/2 mL (10 mg/mL) carton label

NDC 70771-1845-1

Famotidine Injection USP, 20 mg/2 mL (10 mg/mL)

FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS

2 mL Single-Dose Vials

Rx only

20 mg/2 mL (10 mg/mL) vial label
FAMOTIDINE 
famotidine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1846
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE40 mg  in 4 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTIC ACID (UNII: 30KYC7MIAI)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1846-610 in 1 CARTON02/11/2024
1NDC:70771-1846-14 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582802/11/2024
FAMOTIDINE 
famotidine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1847
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE200 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTIC ACID (UNII: 30KYC7MIAI)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1847-610 in 1 CARTON02/11/2024
1NDC:70771-1847-120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582802/11/2024
FAMOTIDINE 
famotidine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1845
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTIC ACID (UNII: 30KYC7MIAI)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1845-725 in 1 CARTON02/11/2024
1NDC:70771-1845-12 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582802/11/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1846, 70771-1847, 70771-1845) , ANALYSIS(70771-1846, 70771-1847, 70771-1845)

Revised: 8/2023
Document Id: 6c2dd6fd-9bf9-4046-8166-86d8816be1cb
Set id: cf3aa86f-c6da-4bd3-ad1c-2a2cb0067f05
Version: 1
Effective Time: 20230802
 
Zydus Lifesciences Limited